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Biologic License Application (BLA): 125249
Company: KINIKSA PHARMACEUTICALS (UK), LTD.
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARCALYST RILONACEPT 220MG VIAL; SINGLE-USE Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/27/2008 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125249lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125249s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125249s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/18/2021 SUPPL-49 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125249s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125249Orig1s049ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/125249Orig1s049.pdf
12/18/2020 SUPPL-47 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125249s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125249Orig1s047ltr.pdf
02/12/2020 SUPPL-45 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125249s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125249Orig1s045ltr.pdf
09/30/2010 SUPPL-18 Supplement

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/18/2021 SUPPL-49 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125249s049lbl.pdf
12/18/2020 SUPPL-47 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125249s047lbl.pdf
02/12/2020 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125249s045lbl.pdf
02/27/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125249lbl.pdf
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